Cemiplimab

Extended indication	Cemiplimab is being investigated in recurrent, persistent, and/or metastatic cervical cancer (2L mono) with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy). Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer).
Therapeutic value	No estimate possible yet
Total cost	7,280,000.00
Registration phase	Registration application pending

Product

Active substance	Cemiplimab
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Cervical cancer
Extended indication	Cemiplimab is being investigated in recurrent, persistent, and/or metastatic cervical cancer (2L mono) with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy). Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer).
Proprietary name	Libtayo
Manufacturer	Sanofi
Mechanism of action	PD-1 / PD-L1 inhibitor
Route of administration	Intravenous
Therapeutical formulation	Infusion fluid
Budgetting framework	Intermural (MSZ)
Additional remarks	PD-1 receptor antagonist

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	November 2021
Expected Registration	December 2022
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	De fabrikant verwacht registratie rond december 2022.

Therapeutic value

Current treatment options	Bevacizumab, chemotherapie.
Therapeutic value	No estimate possible yet
Frequency of administration	1 times every 3 weeks
Dosage per administration	350 mg
References	NCT03257267

Expected patient volume per year

Patient volume	< 80 Market share is generally not included unless otherwise stated.
References	Horizonscan Geneesmiddelen; pembrolizumab + chemo (1L combo) cervical cancer, NKR 2019 incidentie baarmoederhalskanker
Additional remarks	Het cervixcarcinoom wordt in Nederland jaarlijks bij ongeveer 912 vrouwen vastgesteld. Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor eerstelijnsbehandeling met pembrolizumab in combinatie met chemo. Voor de tweedelijn monotherapie cemiplimab komt hierdoor naar verwachting een deel van deze groep in aanmerking.

Patient volume

< 80

Market share is generally not included unless otherwise stated.

References

Horizonscan Geneesmiddelen; pembrolizumab + chemo (1L combo) cervical cancer, NKR 2019 incidentie baarmoederhalskanker

Additional remarks

Het cervixcarcinoom wordt in Nederland jaarlijks bij ongeveer 912 vrouwen vastgesteld. Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor eerstelijnsbehandeling met pembrolizumab in combinatie met chemo. Voor de tweedelijn monotherapie cemiplimab komt hierdoor naar verwachting een deel van deze groep in aanmerking.

Expected cost per patient per year

Cost	91,000.00
References	Lijstprijs zoals vermeld in de G-Standaard van Z-Index
Additional remarks	1 maal per 3 weken €5.721,10 inclusief btw. dus €5.248,72 exclusief btw. Uitgaande van een heel behandeljaar zouden de kosten maximaal zo'n €91.000 betreffen.

Potential total cost per year

Total cost	7,280,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Total cost

7,280,000.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension	Yes
Indication extensions	NSCLC
References	Fabrikant

Other information

There is currently no futher information available.